(97 days)
The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension Vista® System. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome.
The CHEM 3 CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (CO2) and Ethyl Alcohol (ETOH) methods on the Dimension Vista" System.
The Dimension Vista® Ammonia assay (AMM) is an enzymatic method that uses glutamate dehydrogenase (GLDH) and a stabilized NADPH analog. Ammonia reacts with a-ketoglutarate and reduced cofactor to form L-glutamate and the cofactor. The reaction is catalyzed by glutamate dehydrogenase. The decrease in absorbance due to the oxidation of the reduced cofactor is monitored at 340/700 nm and is proportional to the ammonia concentration.
The Dimension Vista® Ammonia (AMM) Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic cartridge for use on the Dimension Vista® System.
The Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) is a two level, liquid calibrator. It is packaged as a kit of six vials with 2.5 mL per vial. The product is a multi-analyte, aqueous product containing ammonium bicarbonate, sodium carbonate and ethyl alcohol.
The provided document describes the Siemens Dimension Vista® Ammonia Flex® reagent cartridge (AMM) and Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) and their performance characteristics. As a laboratory assay and calibrator, the concept of "acceptance criteria" and "device performance" relates to analytical performance metrics rather than diagnostic accuracy as would be the case for an AI medical device. Similarly, concepts like "sample size used for the test set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "ground truth" are not directly applicable in the context of validating an in vitro diagnostic reagent and calibrator kit.
However, I can extract the relevant analytical performance characteristics and compare them to accepted standards (often implied by the CLSI guidelines referenced).
Here's an interpretation of the requested information, adapted to the context of an in vitro diagnostic (IVD) reagent and calibrator:
Acceptance Criteria and Study to Prove Device Meets Criteria
The studies conducted for the Siemens Dimension Vista® Ammonia Flex® reagent cartridge (AMM) and Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) evaluate their analytical performance against established guidelines (primarily CLSI standards). The 'acceptance criteria' are generally understood to be meeting these established analytical performance benchmarks to demonstrate substantial equivalence to predicate devices and ensure reliable test results.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied by CLSI Guidelines & Predicate Equivalence) | Reported Device Performance (AMM Assay) |
|---|---|---|
| Method Comparison | High correlation (r > 0.975), acceptable slope (0.95-1.05), and intercept against predicate device. | Correlation: r = 0.993 (AMM vs. Dimension® AMON) Slope: 1.03 Intercept: 13.6 µg/dL [8.0 µmol/L] |
| Plasma Equivalency | High correlation (r > 0.975), acceptable slope (0.95-1.05), and intercept between different plasma types. | Correlation: r = 1.00 (Lithium Heparin vs. EDTA) Slope: 0.96 Intercept: 3.3 µg/dL [2.0 µmol/L] |
| Reference Interval | Validation of existing reference interval by transference or establishment of new interval. | Validated transference of 19 - 54 µg/dL [11 - 32 µmol/L] from predicate. |
| Precision | Acceptable %CV for repeatability and within-lab variability across different analyte levels. | Repeatability %CV: Level 1 (6.1), Level 2 (1.2), Level 3 (0.6) Within-Lab %CV: Level 1 (7.5), Level 2 (1.7), Level 3 (0.9) |
| Linearity (Analytical Measurement Range) | Demonstrated linear response over the claimed range. | 17 - 1277 µg/dL [10 - 750 µmol/L] |
| Interference | Bias due to interfering substances < 10% (or defined acceptable limits). | Certain substances (Hemoglobin, Bilirubin (conjugated), Lipemia) showed >10% bias at specific concentrations for some ammonia levels. Further analysis showed no significant interference for certain endogenous interferents at specific analyte level based on recovery within 10% of expected value. |
| Limit of Blank (LoB) | LoB value that supports the claimed analytical range. | 4 µg/dL [2 µmol/L] (Claimed LoB: 9 µg/dL [5 µmol/L]) |
| Limit of Detection (LoD) | LoD value that supports the claimed analytical range. | 15 µg/dL [9 µmol/L] (Claimed LoD: 17 µg/dL [10 µmol/L]) |
| Limit of Quantitation (LoQ) | LoQ value that supports the claimed analytical range. | 17 µg/dL [10 µmol/L] (Claimed LoQ: 17 µg/dL [10 µmol/L]) |
2. Sample Size Used for the Test Set and the Data Provenance
- Method Comparison: 100 patient samples. Provenance is not explicitly stated (e.g., country of origin) but inferred to be clinical laboratory samples. Data type is prospective, as fresh samples were tested.
- Plasma Equivalency: 49 fresh matched lithium heparin and EDTA plasma samples. Provenance is not explicitly stated. Data type is prospective.
- Precision: Not explicitly stated as "sample size" in the context of unique patient samples, but testing involved "three levels of Liquicheck™ Ethanol/Ammonia control" tested over 20 days, two separate runs with two test samples for each test material (effectively 3 levels * 20 days * 2 runs * 2 replicates = 240 measurements for each level during repeatability and within-lab assessment).
- Linearity, LoB, LoD, LoQ: The number of unique patient samples is not specified. Studies utilized specific control materials and diluted samples tested across multiple days, runs, and replicates (e.g., for LoB, 4 blank samples tested for 3 days, 1 run/day, 2 replicates/run).
- Interference: Tested with specific concentrations of interfering substances (e.g., 75 mg/dL Hemoglobin) and tested at two analyte concentrations (85 µg/dL and 426 µg/dL). The number of unique patient samples for interference testing is not explicitly stated for all tests, but for certain endogenous interferents which exceeded 10% bias, an aliquot of a patient sample containing the potential interferent was mixed with a plasma pool.
Data provenance is from laboratory studies performed at Siemens Healthcare Diagnostics, Inc. on Dimension Vista® 1500 System, implying a retrospective analysis of collected lab data or controlled prospective lab studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This concept is not applicable to the validation of an IVD reagent and calibrator. The "ground truth" for analytical performance studies is typically established by:
- The results from a legally marketed predicate device (for method comparison).
- Defined reference materials (e.g., control solutions, calibrators).
- Known concentrations in spiked samples.
- Established clinical laboratory reference intervals.
4. Adjudication Method for the Test Set
Not applicable. This concept relates to expert consensus in interpreting complex data (e.g., images) to establish a "ground truth" for a diagnostic model, which is not relevant for analytical performance studies of a laboratory reagent.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
Not applicable. MRMC studies are used for diagnostic devices that involve human interpretation of results (e.g., radiology images). This document describes an automated laboratory assay. The closest equivalent is the "Method Comparison" study, which compares the new device's analytical results to those of an established predicate device.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no human-in-the-loop AI component is demonstrated.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, the studies presented are all "standalone" in the sense that they evaluate the analytical performance of the assay and calibrator on the Dimension Vista® System without direct human judgment influencing the output of the measurement. The results reported (e.g., correlation, precision, linearity) represent the performance of the device itself.
7. The Type of Ground Truth Used
- Method Comparison: The predicate device, Dimension® Ammonia (AMON) assay (K863840), served as the reference or "ground truth" for comparison.
- Plasma Equivalency: Matched samples of different plasma types were compared, with one type serving as a reference point.
- Precision: Standardized control materials (Liquicheck™ Ethanol/Ammonia control) with known or expected ranges.
- Linearity, LoB, LoD, LoQ: Serial dilutions of samples with known concentrations or blank samples, evaluated against expected analytical behavior.
- Interference: Control samples without interferent compared to test samples with known concentrations of potential interferents.
- Reference Interval: Transference of reference interval from widely accepted literature (Textbook of Clinical Chemistry by NW Tietz) and validated through CLSI C28-A3 guidelines.
8. The Sample Size for the Training Set
Not applicable. This device is an IVD reagent and calibrator, not an AI/ML algorithm that requires a "training set" in the computational sense. The development of such reagents involves chemical and enzymatic research, formulation, and optimization rather than data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for performance evaluations (as described in point 7) is based on established analytical chemistry principles, predicate device performance, and reference materials.
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510k Summary
MAR 0 7 2013
Dimension Vista® Ammonia Flex® reagent cartridge (AMM) Dimension Vista® Chem 3 Calibrator (CHEM 3 CAL)
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. 510(k) Number
-
Applicant: Rose T. Marinelli Siemens Healthcare Diagnostics, Inc. P.O. Box 6101, Newark, DE 19714-6101 Office Number: 302-631-8805; Fax Number: 302-631-6299
-
Date: November 28, 2012
4. Proprietary and Established Names:
Dimension Vista® Ammonia Flex® reagent cartridge, (AMM) Dimension Vista® Chem 3 Calibrator (CHEM 3 CAL)
5. Regulatory Information:
Ammonia (AMM) Flex® reagent cartridge
Requlation section: 21 CFR 862.1065 Enzymatic Method, Ammonia Classification: Class I Product Code: JIF Panel: Clinical Chemistry
Chemistry 3 Calibrator (CHEM 3 CAL)
Regulation section: 21 CFR 862.1150 Calibrator, Secondary Classification: Class II Product Code: JIX Panel: Clinical Chemistry
6. Predicate Devices:
The predicate device used to demonstrate substantial equivalence to the Dimension® Ammonia (AMM) Flex® reagent cartridge is the Dimension® Ammonia (AMON) previously cleared under K863840.
The predicate device used to demonstrate substantial equivalence to the Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) is the Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) previously cleared under K062334.
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7. Device Description:
The Dimension Vista® Ammonia assay (AMM) is an enzymatic method that uses glutamate dehydrogenase (GLDH) and a stabilized NADPH analog. Ammonia reacts with a-ketoglutarate and reduced cofactor to form L-glutamate and the cofactor. The reaction is catalyzed by glutamate dehydrogenase. The decrease in absorbance due to the oxidation of the reduced cofactor is monitored at 340/700 nm and is proportional to the ammonia concentration.
GLDH NHa* + reduced cofactor -> -> - L-glutamate + cofactor + H2O a-ketoglutarate +
The Dimension Vista® Ammonia (AMM) Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic cartridge for use on the Dimension Vista® System. Flex® reagent cartridges hold reagents for a test method. Each Dimension Vista® Flex · has twelve wells.
| Wellsa1 - 12 | Form | Ingredient | Concentrationb,c | Source |
|---|---|---|---|---|
| Liquid | $\alpha$-ketoglutarateGLDHNADPH | 10 mmol/L$\geq$ 24 KU/L0.2 mmol/L | Microbial |
Wells are numbered consecutively from the wide end of the cartridge. a.
Nominal value per well in a cartridge. ﻀ
Contain buffers, stabilizers and preservatives. C.
Reagent preparations are performed automatically on the instrument. A barcode label on the cartridge identifies the test method, lot number, expiration date and maximum number of tests for which the cartridge can supply reagent.
The Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) is a two level, liquid calibrator. It is packaged as a kit of six vials with 2.5 mL per vial. The product is a multi-analyte, aqueous product containing ammonium bicarbonate, sodium carbonate and ethyl alcohol. This product is sold separately from the Flex® reagent cartridge.
8. Intended Use:
The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension Vista® System. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome.
The CHEM 3 CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (CO2) and Ethyl Alcohol (ETOH) methods on the Dimension Vista" System.
9. Indication(s) for Use:
The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension Vista® System. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome.
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The CHEM 3 CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (CO2) and Ethyl Alcohol (ETOH) methods on the Dimension Vista" System.
10. Substantial Equivalence Information:
Both the Dimension Vista® Ammonia Flex® reagent cartridge (AMM) assay and the predicate Dimension® Ammonia Flex® reagent cartridge (AMON) assay employ prepackaged reagents for use on automated clinical chemistry test systems. A comparison of the similarities and differences between the devices is provided in the following tables.
Note: Siemens has decided to offer our customers both conventional units and Systéme International d'Unités (SI units) in the Instructions for Use (IFU). The predicate, Dimension® Ammonia (AMON) assay results are reported in SI Units only. All data supplied in Appendix C will include both conventional units and SI Units for ease of review. Raw data was collected from the instruments in SI units and the conventional units were calculated using the following equation: ug/dL x 0.587 = [umol/L].
| Feature | New Device : Dimension Vista®Ammonia Flex® reagentcartridge (AMM) | Predicate: Dimension®Ammonia Flex® reagentcartridge (AMON) K863840 |
|---|---|---|
| Intended Use | The AMM method is an in vitrodiagnostic test for the quantitativemeasurement of ammonia inhuman plasma on the DimensionVista® System. Ammoniameasurements are used in thediagnosis and treatment of severeliver disorders such as cirrhosis,hepatitis and Reye's syndrome. | The AMON method used on theDimension® clinical chemistrysystem is an in vitro diagnostictest intended for the quantitativedetermination of ammonia inhuman plasma. |
| Format | Prepackaged for use on anautomated system. | Prepackaged for use on anautomated system. |
| Measurement | Bichromatic Rate | Bichromatic Rate |
Similarities for Dimension Vista® AMM assay:
Differences for Dimension Vista® AMM assay:
| Feature | New Device: Dimension Vista®Ammonia Flex® reagentcartridge (AMM) | Predicate: Dimension®Ammonia Flex® reagentcartridge (AMON) K863840 |
|---|---|---|
| MeasuringRange | 17-1277 µg/dL [10 - 750 µmol/L] | 0 - 1000 µmol/L |
| Sample Type | Plasma (Lithium Heparin andEDTA) | Plasma (EDTA, Lithium Heparin,Sodium Fluoride) |
| Reagent Form | Liquid | Tablet |
| Units | µg/dL and µmol/L | µmol/L |
| Sample Size | 20 µL | 53 µL |
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Similarities for Dimension Vista® CHEM 3 CAL:
| Feature | New Device: Dimension Vista®Chem 3 Calibrator (CHEM 3 CAL) (KC130A) | Predicate: Dimension Vista®Chem 3 Calibrator (CHEM 3 CAL) (KC130) |
|---|---|---|
| Intended Use | The CHEM 3 CAL is an in vitrodiagnostic product for thecalibration of Carbon Dioxide(CO2) and Ethyl Alcohol (ETOH)methods on the Dimension Vista®System. | The CHEM 3 CAL is an in vitrodiagnostic product for thecalibration of Carbon Dioxide(CO2) and Ethyl Alcohol (ETOH)methods on the Dimension Vista®System. |
| Preparation | Liquid: Ready to use | Liquid: Ready to use |
| Storage | 2 – 8 °C | 2 - 8 °C |
| Traceability | AMM - ASC Grade AmmoniumSulfateECO2 - NIST SRM 351ETOH - USP Grade EthylAlcohol | AMM - ASC Grade AmmoniumSulfateECO2 - NIST SRM 351ETOH - USP Grade Ethyl Alcohol |
| Matrix | Aqueous product containing ethylalcohol, ammonium bicarbonateand sodium carbonate. | Aqueous product containing ethylalcohol, ammonium bicarbonateand sodium carbonate. |
| TargetConcentrations | EC02 - CAL A - 0 mmol/LCAL B - 50 mmol/LETOH - CAL A - 0 mg/dLCAL B - 315 mg/dL | EC02 - CAL A - 0 mmol/LCAL B - 50 mmol/LETOH - CAL A - 0 mg/dLCAL B - 315 mg/dL |
Differences for Dimension Vista® CHEM 3 CAL
.
| Feature | New Device: Dimension Vista®Chem 3 Calibrator (CHEM 3CAL) (KC130A) | Predicate: Dimension Vista®Chem 3 Calibrator (CHEM 3CAL) (KC130) |
|---|---|---|
| Intended Use | The CHEM 3 CAL is an in vitrodiagnostic product for thecalibration of Ammonia (AMMmethod on the Dimension Vista®System. | The CHEM 3 CAL is an in vitrodiagnostic product for thecalibration of Ammonia (AMON),method on the Dimension Vista®System. |
| TargetConcentrationsfor AMM | Calibrator A: 0 μg/dL[μmol/L]Calibrator B: 1405 μg/dL[825 μmol/L] | Calibrator A: 0 μmol/LCalibrator B: 1000 μmol/L |
| Units | μg/dL and μmol/L | μmol/L |
:
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11. Standard/Guidance Document Reference:
- · Evaluation of Precision Performance of Quantitative Measurement in Methods; Approved Guideline (EP5-A2)
- · Evaluation of the Linearity of Quantitative Measurement Procedures; A Statistical Approach; Approved Guideline (EP6-A)
- · Interference Testing in Clinical Chemistry; Approved Guideline (EP7-A2)
- · Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (EP9-A2)
- · Protocols for Determination of Limits of Detection and Quantitation; Approved Guideline (EP17-A)
- · Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline (C28-A3)
- · Evaluation of Stability of In-Vitro Diagnostic Reagents; Approved Guideline (EP25-A)
12. Performance Characteristics
The following data represent typical performance for the Dimension Vista® System and were collected on a Dimension Vista® 1500 System.
Method Comparison
Split sample comparison between the Dimension Vista® Ammonia (AMM) assay and the Dimension Vista Ammonia (AMON) assay gave the following correlation statistics, when tested with patient samples:
| DimensionVista® | Predicate | Slope | Interceptµg/dL [µmol/L] | CorrelationCoefficient (r) | n |
|---|---|---|---|---|---|
| AMM | Dimension®AMON | 1.03 | 13.6 µg/dL[8.0 µmol/L] | 0.993 | 100 |
Dimension Vista® Ammonia (AMM) vs. Predicate
Plasma Equivalency Comparison
To demonstrate equivalency between lithium heparin plasma for Dimension Vista " AMM assay, comparison testing of 49 fresh matched lithium heparin and EDTA plasma samples were tested on the Dimension Vista® System and gave the following linear regression statistics:
Plasma Equivalency Comparison Data
| LithiumHeparin vs. | Slope | Interceptμg/dL [μmol/L] | CorrelationCoefficient (r) | n |
|---|---|---|---|---|
| EDTA | 0.96 | 3.3 [2.0] | 1.00 | 49 |
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Reference Interval (Expected Values)
The reference interval of 19 - 54 ug/dL [11 - 32 umol/L] for the predicate was validated for use with the Dimension Vista® Ammonia (AMM) assay by transference following CLSI C28-A3 Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory - Approved Guideline - Third Edition. The literature reference used was the Textbook of Clinical Chemistry by NW Tietz; WB Saunders Co., Philadelphia, PA; pages 1487-1488.
Expected Values: 19 - 54 µq/dL [11 - 32 µmol/L]
Precision
Precision testing was performed in accordance with CLSI EP5-A2 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition. Samples consisted of three levels of Liquicheck™ Ethanol/Ammonia control. Testing was performed over 20 days, two separate runs with two test samples for each test material. Analysis of variance (ANOVA) was used to evaluate the data consistent with the recommendations of EP5-A2. The data are summarized in the following Dimension® Ammonia (AMM) Summary Table:
| Material | Meanµg/dL [ µmol/L] | Standard Deviation (%CV)Repeatabilityµg/dL [µmol/L] %CV | Within-Lab | ||
|---|---|---|---|---|---|
| Liquichek™ Ethanol/Ammonia control | |||||
| Level 1 | 44 | [26] | 2.7[1.6] | (6.1) | 3.3[1.9] (7.5) |
| Level 2 | 186 | [109] | 2.3 [1.4] | (1.2) | 3.2 [1.9] (1.7) |
| Level 3 | 563 | [331] | 3.5 [2.1] | (0.6) | 5.0 [2.9] (0.9) |
Linearity
The linear range was determined according to CLSI EP-6A. Evaluation of the Linearity of Quantitative Measurement Procedures; A Statistical Approach; Approved Guideline. Based on the results of this testing and the Limit of Detection testing on the Dimension Vista" System, the analytical measurement range was determined to be 17 - 1277 µg/dL [10 - 750 µmol/L].
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Image /page/6/Figure/0 description: The image is a scatter plot comparing observed AMM to expected AMM, both measured in micrograms per deciliter. The data points form a nearly perfect linear relationship. A line of best fit is shown, with the equation y = 0.99x + 3.74 and an R-value of 1.00, indicating a very strong positive correlation.
Analytical Specificity/Interferences
Interfering Substances
The AMM assay was evaluated for interference according to CLSI EP7-A2 Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition. Bias is the difference in the results between the control sample (without the interferent) and the test sample (contains the interferent) expressed in percent. Bias exceeding 10% is considered interference.
| Substance Tested | Substance Concentration | Ammoniaµg/dL [µmol/L] | Bias% |
|---|---|---|---|
| Hemoglobin(hemolysate) | 75 mg/dL [0.05 mmol/L]500 mg/dL [0.62 mmol/L] | 85 [50]426 [250] | +12+17 |
| Bilirubin(unconjugated) | 80 mg/dL [1026 µmol/L] | 85 [50]426 [250] | <10<10 |
| Bilirubin(conjugated) | 60 mg/dL [1026 µmol/L]80 mg/dL [1368 µmol/L] | 85 [50]426 [250] | -16<10 |
| Lipemia(Intralipid®) | 50 mg/dL [0.565 mmol/L]50 mg/dL [0.565 mmol/L] | 85 [50]426 [250] | +13<10 |
See Limitations of Procedure for complete listing of substances that exceeded a bias of <10%.
Studies were also performed following CLSI EP7-A2 for Interference Testing of exogenous substances at ammonia concentrations of 85 µg/dL [50 µmol/L] and 426 µg/dL [250 µmo//L] and were found not to interfere with the AMM method when present in plasma. Inaccuracies (biases) were all less than 10%. See Dimension® AMM Instructions for Use for a full list of substances tested.
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The AMM assay was evaluated for interference according to CLSI/NCCLS EP7-A2. Bias is the difference in the results between the control sample (without the interferent) and the test sample (contains the interferent) expressed in percent. Bias exceeding 10% is considered interference. Testing was performed at two levels of analyte concentration.
| Analyte Test Level | 85 µg/dL [50 µmol/L] | ||
|---|---|---|---|
| Interferent | [Test] mg/dL | [Test] SIUnits | Bias(%) |
| Albumin | 6 g/dL | 60 g/L | 49 |
| Bilirubin(conjugated) | 60mg/dL | 1026 µmol/L | -16 |
| Cholesterol | 503 mg/dL | 13 mmol/L | 65 |
| Creatinine | 30 mg/dL | 2.65 mmol/L | 34 |
| Dextran 40 | 500 mg/dL | 125 µmol/L | 13 |
| Hemoglobin | 75 mg/dL | 0.05 mmol/L(monomer) | 12 |
| Immunoglobulin G | 5 g/dL | 50 g/L | 30 |
| Lipemia (Intralipid®) | 50 mg/dL | 0.5 g/L | 13 |
| Triglycerides | 3000 mg/dL | 33.9 mmol/L | * |
| Uric Acid | 20 mg/dL | 1.2 mmol/L | 43 |
*Tripped a test report message; therefore magnitude of the interference could not be determined.
| Analyte Test Level | 426 µg/dL [250 µmol/L] | ||
|---|---|---|---|
| Interferent | [Test] mg/dL | [Test] S.I.Units | Bias(%) |
| Albumin | 6 g/dL | 60 g/L | 15 |
| Cholesterol | 503 mg/dL | 13 mmol/L | 34 |
| Dextran 40 | 3000 mg/dL | 750 µmol/L | 16 |
| Hemoglobin | 500 mg/dL | 0.31 mmol/L | 17 |
| Uric Acid | 20 mg/dL | 1.2 mmol/L | 17 |
For certain endogenous interferents which exceeded 10 % bias, an aliquot of patient sample containing the potential interferent (test) was mixed with equal parts of a plasma pool containing approximately 85 µg/dL [50 µmol/L] ammonia (control). Test samples and control samples were processed and percent recovery calculated from expected and observed values. No significant interference was observed based on recovery within 10% of expected value.
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| SubstanceTested | Test Concentration | AMM concentration | ||
|---|---|---|---|---|
| conventional | SI unit | μg/dL | [μmol/L] | |
| Albumin | 5.4 g/dL | 54 g/L | 182 | [107] |
| Cholesterol | 364 mg/dL | 9.7 μmol/L | 232 | [136] |
| Creatinine | 21.1 mg/dL | 1.87 mmol/L | 233 | [137] |
| Immunoglobulin G | 3.4 g/dL | 34 g/L | 308 | [181] |
| Triglyceride | 1102 mg/dL | 12.3 mmol/L | 354 | [208] |
| Uric Acid | 9.3 mg/dL | 0.6 mmol/L | 196 | [115] |
Limit of Blank, Limit of Determination and Limit of Quantitation
The Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) was evaluated in accordance with CLSI EP17-A Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. Studies were performed on the Dimension® clinical chemistry analyzer with the following results:
| Dimension® Ammonia (AMM) | ||
|---|---|---|
| Limit | Protocol | Value |
| LoB | 4 blank samples were testedfor 3 days, one run per day, 2replicates per run, 2 reagentlots, 1 instrument | 4 µg/dL [2 µmol/L] |
| LoD | 4 low level ammonia sampleswere tested for 3 days, onerun per day, 2 replicates perrun, 2 reagent lots, 1instrument | 15 µg/dL [9 µmol/L] |
| LoQ | 3 low level samples dilutedwith purified water were testedfor 3 days, one run per day, 3replicates per run, 2 reagentlots, 1 instrument | 17 µg/dL [10 µmol/L] |
These results support the claims of a LoB of 9 µg/dL [5 µmol/L], 17 µg/dL [10 µmo//L] for LoD and 17 µg/dL [10 µmol/L] for LoQ.
Calibrator
•
- Once the vial is punctured, assigned values are stable for 24 hours stored on the . Dimension Vista® System.
- . Once cap is removed, assigned values are stable for 30 days when recapped immediately after use and stored at 2-8°C. Do not use this vial on board the instrument.
The shelf life of the Dimension Vista® CHEM 3 CAL is 12 months.
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- Conclusion: The Dimension Vista® Ammonia (AMM) Flex® reagent cartridge assay and the associated Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) are substantially equivalent asobalized Dimension visa - Bitenton (Grimm) - സമ്പന്മന - സ്ഥിത (AMON) assay and the
in principle and performance to the predicates, Dimension (AMON) assay and the
Dimension
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized emblem with three curved shapes resembling ribbons or waves, positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2013
Siemens Healthcare Diagnostics, Inc. c/o Rose T. Marinelli P.O. Box 6101 500 GBC Drive, M/S 514 Newark, DE 19702
Re: K123677
Trade/Device Name: Dimension Vista Ammonia Flex reagent cartridge (AMM) and Dimension Vista Chemistry 3 Calibrator (CHEM 3 CAL)
Regulation Number: 21 CFR 862.1065 Regulation Name: Ammonia test system Regulatory Class: Class I, reserved Product Code: JIF, JIX Dated: January 31, 2013 Received: February 01, 2013
Dear Ms. Marinelli:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part · 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol G. Benson - S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123677
Device Name: Dimension Vista® Ammonia Flex® reagent cartridge (AMM)
Indications for Use:
The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma (heparin or EDTA) on the Dimension Vista System. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
YungWDChan-S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K123677
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Indications for Use
510(k) Number (if known): K123677
Device Name: Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL)
Indications for Use:
The CHEM 3 CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (C02) and Ethyl Alcohol (ETOH) methods on the Dimension Vista® System.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
YungW.Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K123677
§ 862.1065 Ammonia test system.
(a)
Identification. An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.(b)
Classification. Class I.